NCT05769946已完成2 期
A Phase II Study to Evaluate the Efficacy and Safety of Hemay005 Tablet in Adult With Moderate to Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 79
- 试验地点
- 1
- 主要终点
- EASI-75
研究概览
简要总结
A multicenter, randomized, double-blind, placebo-controlled, phase II study to evaluate the efficacy and safety of Hemay005 tablet in the treatment of moderate to severe atopic dermatitis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Understand and voluntarily sign the informed consent form for this study;
- •18-75 years old (including boundary value) , gender is not limited;
- •Ability to adhere to follow-up schedules and other program requirements;
- •According to Hanifin & Rajka diagnostic criteria of atopic dermatitis (AD) , the patients with AD history ≥6 months;
- •At baseline, the severity of AD was moderate to severe: IGA score was 3 or more, and the area of involved skin lesion was 10% BSA or more;
- •Participants were required to use contraception during the study period.
排除标准
- •A medical history unsuitable for participation in a clinical study；
- •Pregnant or lactating women；
- •Allergic to the drug or its preparation；
- •Patients who had undergone major surgery within 6 months before screening or who were scheduled for major surgery during the trial period；
- •Participants who had participated in any drug or device clinical trial within the previous 3 months were screened；
- •Vaccination with live or attenuated vaccines is planned for the duration of the trial；
- •Any drugs is taking that may affect the effectiveness evaluation;
- •Any clinically significant abnormality in 12-lead ECG at screening that was judged by the investigator as unsuitable for inclusion；
- •When investgater believe that any condition could lead to unnecessary risks for patients participating in the study.
研究组 & 干预措施
placebo
Placebo Comparator
Atopic dermatitis patients treated with placebo for 12 week.
干预措施: Hemay005 (Drug)
Hemay005 60mg
Experimental
Atopic dermatitis patients treated with Hemay005 60mg BID for 12 week.
干预措施: Hemay005 (Drug)
Hemay006 75mg
Experimental
Atopic dermatitis patients treated with Hemay005 75mg BID for 12 week.
干预措施: Hemay005 (Drug)
结局指标
主要结局
EASI-75
时间窗: week 12
Percentage of subjects reaching 75% or higher improvement from baseline
次要结局
未报告次要终点
研究者
研究点 (1)
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